FDAJuly 2, 2024device

Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.

What to do

FDA enforcement status: Ongoing

Brands named

stryker sustainability solutionsstrykerstryker sustainability

UPCs

07613327483918

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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